Capillary Blood Collection Device For Alternative Site Collection

PRJ · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1675

Classification

FDA Product Code: PRJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1675
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown